Abiomed and Oscor advise correction of Impella catheter introducers due to leakage risk

Abiomed and its partner Oscor have issued a notice about a potential leakage in certain catheter introducer sheaths used with Impella heart pumps.

The issue involves 14Fr and 23Fr introducer kits, which could increase the chance of access-site bleeding. The FDA has classified the recall as the most serious type because continued use without correction could cause serious injury or death.

The companies recommend that all affected introducer kits be corrected before further use, but the devices do not need to be removed from inventory or from patients already treated.

Specific product codes and GTINs for the affected kits are listed in the notice, covering both kit sets and single-sale packaging.